Perrigo’s Miconazole Generic Gains FDA Approval

Perrigo Co. has received approval from the FDA for its aNDA for OTC Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat -1 Combination Pack, for the treatment of vaginal yeast infections. Perrigo expects to begin shipping immediately. The approval includes 180 days of generic marketing exclusivity.

Perrigo’s chairman and chief executive officer Joseph C. Papa concluded, “This is another example of Perrigo’s commitment to innovation by challenging brand patents and bringing new products to market. These innovations help save OTC healthcare consumers more than an estimated $1 billion annually.”